510(k) K880943

MICROLINE CAT #100 by Microline Pentax, Inc. — Product Code HQE

K880943 is an FDA 510(k) premarket notification submitted by Microline Pentax, Inc. for the device "MICROLINE CAT #100". The FDA issued a decision of Substantially Equivalent on May 26, 1988. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Microline Pentax, Inc. has at least 10 other 510(k) clearances on record.